ATELLICA IM

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER REPORTED OBSERVATION OF ELEVATED ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. SIEMENS REVIEWED THE INSTRUMENT DATA AND THE INFORMATION PROVIDED BY THE CUSTOMER. A REVIEW OF THE SYSTEM MESSAGE LOGS DID NOT SHOW ANY ALERTS OR ERRORS RELATED TO THE REAGENT PACKS, AND NO HARDWARE ISSUES WERE IDENTIFIED. ADDITIONALLY, A REVIEW OF THE SAMPLE AND REAGENT TRACE FILES DID NOT IDENTIFY SAMPLE OR REAGENT ASPIRATION OR DISPENSE ISSUES. ALTHOUGH THE OPERATORS WERE FAMILIAR WITH THE SPECIFIC MIXING PROCEDURE REQUIRED FOR THE ASSAY, PROPER EXECUTION DEPENDS ON THE INDIVIDUAL WHO PERFORMED THE LOADING, AND IT CANNOT BE CONFIRMED THAT THE PROCEDURE WAS CARRIED OUT IN ACCORDANCE WITH THE RECOMMENDED INSTRUCTIONS. RETURN OF THE PATIENT SAMPLES FOR FURTHER INVESTIGATION WERE NOT WARRANTED BECAUSE THE DISCORDANT RESULTS WERE NOT REPRODUCIBLE. BASED ON THE AVAILABLE INFORMATION, THE PROBABLE CAUSE OF THE ELEVATED CEA RESULTS COULD NOT BE DETERMINED. A PRODUCT PROBLEM WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING.

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING LOT# 226. THE CUSTOMER PERFORMED A ROUTINE RESET FOLLOWING A FAILURE IN THE ASSAY¿S MOVING AVERAGE. INITIAL ELEVATED RESULTS WERE OBTAINED FOR TWO PATIENT SAMPLES IN QUESTION. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE ANALYZER WHICH PRODUCED LOWER RESULTS. THE LOWER RESULTS WERE CONSIDERED CORRECT BASED ON THE CLINICAL ASSESSMENT AND CORRECTED REPORTS WERE ISSUED TO THE PHYSICIAN(S). THE CUSTOMER DID NOT CONFIRM WHETHER THE PATIENTS HAD ANY PRIOR CANCER DIAGNOSIS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.